Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery

Hospital Clinic of Barcelona

Status: Completed

Conditions: Anxiety; Colorectal Cancer

Treatments: Behavioral: Virtual Reality Software

Study type: Interventional

Funder types: Other

Identifiers

NCT04058600

HCB/2018/0290 CIF-G-08431173

Details and patient eligibility

About

A prospective controlled randomized interventional study comparing the effects of the preoperative exposure to a virtual reality software versus not exposure in 126 patients with colorectal cancer. Patients will be divided in two randomized groups, each of them of 63 patients. The hypothesis of the study is that gradual exposure to the hospital environment using a virtual reality software is effective to reduce preoperative anxiety.

The main variable is the level of anxiety in patients undergoing colorectal cancer surgery. It will be measured using State-Trait Anxiety Inventory Scale (STAI-S) and the Hospital Anxiety and Depression Scale (HADS).

Full description

Colorectal cancer is the third most frequent neoplasia diagnosed worldwide, and in Spain it is the first in incidence and prevalence, accounting for 15% of all neoplasias according to World Health Organization (WHO).

The incidence of preoperative anxiety in patients undergoing elective surgery is high (60% - 76%). There are many causes for this: anticipation of postoperative pain, loss of independence, separation from the family, fear to the surgical procedure or to severe complications or even death. The incidence of preoperative anxiety varies according to age, sex, educational leve, previous exposure to surgical interventions and the expected impact of the surgical procedure in global quality of life.

Patients with anxiety require higher dosis of induction anesthesia, longer hospital stay, and a higher rate of perioperative complications due to a release of catecholamines, increase on the oxidative demands, causing tachycardia, arrhythmia, high blood pressure, etc.

Gradual exposition is considered an effective way of reducing anxiety. It has been demonstrated that anxiety is decreased in patients with history of surgical interventions, and thus the experience is experimented as an adaptive process. Virtual reality gives the opportunity to experience each of the steps of the hospital stay in a realistic environment.

The hypothesis of this study is that gradual exposure to the hospital environment using virtual reality is an effective tool to reduce preoperative anxiety in patients undergoing colorectal cancer surgery.

Enrollment: 126 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed of colorectal cancer requiring elective surgery.
• American Society of Anesthesiologists (ASA) I - III.
• No surgical history.
• Surgical procedure programmed in the next 6 months.

Exclusion criteria

• Neurologic deficits.
• Visual disorder.
• Neuro-psychiatric disorder.
• Use of neuro-psychiatric drugs.
• Non-sphincter-preserving surgery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Virtual Reality

Experimental group

Description:

The patients will be exposed to a virtual reality software that simulates the environment of the hospital, from admission to the operating room and the recovery room.

Treatment:

Behavioral: Virtual Reality Software

Control

No Intervention group

Description:

Patients in this group are not exposed preoperatively to the virtual reality software and are given the standard therapy and cares for their disease.